Genzyme Corp. has been granted marketing approval for Clolar (clofarabine) for the treatment of children with refractory or relapsed acute lymphoblastic leukaemia (ALL) by US FDA.

Clolar is the first new leukaemia treatment approved specifically for children in more than a decade. Given the unmet need for new treatment options in this seriously ill patient population, Genzyme expects to make Clolar commercially available as quickly as possible in January, a company release said.

Susan Weiner, president of The Children's Cause for Cancer Advocacy said, "Children resistant to current treatments badly need new therapeutic options, and hopefully this approval will encourage others in industry to meet the unmet medical needs of these very sick children."

In 2005, an estimated 3,400 new cases of paediatric acute leukaemia will be diagnosed in the United States, according to Cancer Metric. ALL is the most common form of paediatric leukaemia and children who do not respond to initial therapy, or who relapse, have a very poor survival prognosis.

"With this approval, we will now expand our commercial operations, including the creation of Genzyme's first oncology sales force for Clolar," Mark Enyedy, senior vice president and general manager of Genzyme Oncology said adding, "We have worked diligently to make Clolar available to physicians and patients, and are eager to embark on the product launch. This is the first step in our comprehensive development plan for Clolar, which we are also studying for adult leukaemia and solid tumour cancers."

Clolar has received Orphan Drug designation for adult and paediatric acute lymphoblastic leukaemia. Clolar will now have seven years of market exclusivity in paediatric ALL patients. The US FDA also recently granted six months of extended market exclusivity to Clolar under the Best Pharmaceuticals for Children Act.